Microbiome-based drugs likely to face FDA’s biologics pathway

A magnified view of C. difficile bacteria, an early target of microbiome-based therapiesCDC

NEW YORK — It’s not really a stretch of the imagination to think that microbiome companies should care deeply about who will lead the Food and Drug Administration after the current commissioner, Scott Gottlieb, departs in a few weeks. After all, no microbiome-based drug has yet gone through the regulatory process and made it to market and investors are still skittish about how those drugs will be received by the agency.

Yet a five-person panel of microbiome executives on a panel at the inaugural Chardan Microbiome Summit on Thursday didn’t address the shift in leadership until prompted by a member of the audience. And when they did, the response was essentially “meh.”

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